Cleared Abbreviated

K991485 - SYNERGY POROUS SIZE 8 HIP STEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K991485 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
75d
Days
Class 2
Risk

K991485 is an FDA 510(k) clearance for the SYNERGY POROUS SIZE 8 HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on July 12, 1999 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K991485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1999
Decision Date July 12, 1999
Days to Decision 75 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 558
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K991485.
G7® Revision Acetabular System
K252623 · Zimmer, Inc. · Feb 2026
Mpact 3D Metal Implants Extension – DMLS Technology
K251043 · Medacta International S.A. · Jan 2026
Velora Acetabular System
K252067 · Restor3D, Inc. · Dec 2025
TaperSet™ Hip System
K252846 · Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics · Nov 2025
EMPOWR Acetabular® Liner Extension
K251833 · Encore Medical, L.P. · Nov 2025
ArTT Augments and Buttresses and Bone Screws
K251718 · Lima Corporate S.P.A. · Aug 2025